Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

efavirenz, emtricitabine, tenofovir disoproxil maleate

Available from:

Mylan Pharmaceuticals Limited

ATC code:

J05AR06

INN (International Name):

efavirenz, emtricitabine, tenofovir disoproxil

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan prior to initiation of their first antiretroviral treatment regimen.The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2017-09-05

Patient Information leaflet

69
B. PACKAGE LEAFLET
70
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN 600 MG/200 MG/245
MG FILM-COATED TABLETS
efavirenz/emtricitabine/tenofovir disoproxil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is and what it
is used for
2.
What you need to know before you take
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
3.
How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
4.
Possible side effects
5.
How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN IS AND WHAT IT
IS USED FOR
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN CONTAINS THREE
ACTIVE SUBSTANCES
that are
used to treat human immunodeficiency virus (HIV) infection:
-
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
-
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
-
Tenofovir disoproxil is a nucleotide reverse transcriptase inhibitor
(NtRTI)
Each of these active substances, also known as antiretroviral
medicines, work by interfering with an
enzyme (reverse transcriptase) that is essential for the virus to
multiply.
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN IS A TREATMENT FOR
HUMAN
IMMUNODEFICIENCY VIRUS
(HIV) infection in adults aged 18 years and over who have previously
been
treated with other antiretroviral medicines and have their HIV-1
infection under

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245
mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of
emtricitabine and 245 mg of
tenofovir disoproxil (as maleate).
Excipient with known effect
Each film-coated tablet contains 7.5 mg of sodium metabisulfite and
105.5 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink capsule-shaped, biconvex, beveled-edge film-coated tablet,
approximately 21 mm x 11 mm and
debossed with ‘M’ on one side and ‘TME’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose
combination of efavirenz,
emtricitabine and tenofovir disoproxil. It is indicated for the
treatment of human immunodeficiency
virus-1 (HIV-1) infection in adults aged 18 years and over with
virologic suppression to HIV-1 RNA
levels of < 50 copies/ml on their current combination antiretroviral
therapy for more than three
months. Patients must not have experienced virological failure on any
prior antiretroviral therapy and
must be known not to have harboured virus strains with mutations
conferring significant resistance to
any of the three components contained in
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan prior to
initiation of their first antiretroviral treatment regimen (see
sections 4.4 and 5.1).
The demonstration of the benefit of efavirenz/emtricitabine/tenofovir
disoproxil is primarily based on
48-week data from a clinical study in which patients with stable
virologic suppression on a
combination antiretroviral therapy changed to
efavirenz/emtricitabine/tenofovir disoproxil (see
section 5.1). No data are currently available from clinical studies
with
efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in
heavily pretreated patients.
No data are available